FDA urged to prohibit same claims for dietary supplements and OTC drugs

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WASHINGTON - The Center for Science in the Public Interest (CSPI) today petitioned the Food and Drug Administration (FDA) to repeal portions of a labeling regulation that permits manufacturers of dietary supplements to make claims about untested products that are identical to FDA-approved claims for a variety of non-prescription drugs.

     The FDA recently advised supplement manufacturers to disregard one portion of the regulation, issued on January 6, that allowed companies to make claims regarding morning sickness and pregnancy. The agency is holding a public hearing today to further consider that matter. CSPI urged the FDA to take action on more than two dozen other claims.

     Under FDA rules, supplement manufacturers can now make label statements such as “for the relief of occasional sleeplessness,” “for relief of upset stomach,” and “for the prevention of nausea, vomiting, or dizziness associated with motion” without first demonstrating that such products are safe and effective. In contrast, non-prescription drugs that make those identical claims must be proven safe and effective.

     “It’s crazy to allow supplements to bear the exact same claims as non-prescription drugs when only the drugs have been tested and shown to be safe and effective,” stated Ilene Ringel Heller, CSPI senior staff attorney. “We’re not saying that consumers should take non-prescription drugs instead of dietary supplements, but under the FDA’s current policy, untested products are made to seem just as good as tested products.”

     CSPI urged the FDA to ban such claims on supplements or, at a minimum, require manufacturers to qualify them with statements such as “This product is not an over-the-counter drug. This product has not been found to be safe by the U.S. Food and Drug Administration.” Dietary supplements that make claims already must carry a congressionally mandated disclosure that states: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”